R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
FDA 510(k) K181688 · Shenzhen Roundwhale Technology Co. , Ltd.
510(k) numberK181688
Submission
- Device name
- R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
- Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
Shenzhen, CN - Received
- June 26, 2018
- Decision date
- September 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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Questions and answers
When was R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator cleared by the FDA?
R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (K181688) received a 510(k) decision of Substantially Equivalent on September 7, 2018, 73 days after the submission was received.
What is the product code of K181688?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.